Fujifilm ED-250XT5 Endoscope Manual Recall Due to Bacteria Reports
Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (multi-drug resistant bacteria) associated with medical devices, but the source text does not report specific hospitalizations or injuries, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 882 units of the Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage. The recall is a correction issued in response to publicized reports of multi-drug resistant bacteria found on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The affected manuals were distributed nationwide between March 2003 and April 2016. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and users of these manuals should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions regarding the replacement or correction of the documentation.
The recalled product
- Product
- Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Affected units
- 882
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All distribution dates :3/2003-4/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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